Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT02526004
Eligibility Criteria:
Inclusion Criteria:
* Written and informed consent, and assent where required.
* Age 16 years or older at enrolment
* Diagnosis of CF by standard sweat test and/or genetic analysis
* Persistent pulmonary Pseudomonas aeruginosa colonization confirmed on at least 2 occasions in the preceding 12 months
* Screening FEV1 predicted of \>25%
* Able to perform spirometry reproducibly prior to enrolment
* Able to expectorate and provide a sputum sample at least once daily
* ≥1 non-elective course of intravenous antibiotics in the preceding year
* Able to understand and comply with protocol requirements, restrictions and instructions and likely to complete the study as planned, as judged by the investigator
Exclusion Criteria:
* Life expectancy less than 6 months
* They are a solid organ transplant recipient
* Have a requirement for immunosuppression ≥10mg corticosteroids per day
* Previous positive culture of non-tuberculosis mycobacteria species M.avium, M.abscessus or M.intracellulare within the last 12 months or undergoing active therapy
* Positive culture of any Burkholderia cepacia species within the last 12 months or undergoing active therapy
* Allergic bronchopulmonary aspergillosis on treatment
* Known allergies to more than 3 different classes of antibiotics, and intolerance or allergy to tobramycin.
* Liver portal hypertension, determined by identification of oesophageal varices
* Advanced kidney disease requiring a dose reduction of ceftazidime or contraindicating aminoglycosides
* History of any illness that in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject
* If patient undergoes a pulmonary exacerbation before the Microbiome analysis is reviewed by the Consensus Treatment Panel and i.v. antibiotics are administered. In this case, a repeat sputum will be sent for analysis 4 weeks after end of antibiotic treatment.
* Pregnant or breast-feeding at time of eligible pulmonary exacerbation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
80 Years
Study:
NCT02526004
Study Brief:
Protocol Section:
NCT02526004